510(k) K950979 ยท DHN Antinuclear Antibody, Indirect Immunofluorescent, Antigen, Control
HEP-2000 COLORZYME ANA-RO TEST SYSTEM
| Applicant | Immuno Concepts, Inc., Irving TX, US |
| Decision | Substantially Equivalent, Jun 1, 1995 |
| Received | Mar 3, 1995 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K950979
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.